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Severe sepsis is a very complex syndrome [ 44], therefore, even in the RCTs it cannot be ruled out that some of the multiple measured and unmeasured baseline confounders may be unequally balanced with repeated subgroup analyses.
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We repeated the same subgroup analyses on the custom pathway set and in all cases the 'electron transport chain pathway' and the 'erythrocyte/reticulocytespecific_affytechnote' pathways remained the top 2 ranked pathways for all groups tested.
In a series of subgroup analyses we repeated all analyses by parity subgroup for the primary cost effectiveness outcome namely, incremental cost per adverse perinatal outcome avoided.
32 In light of the findings about the explanatory effect for heterogeneity in Cheng 2005, 27 subgroup analyses were repeated by sex, baseline serum vitamin D level, dose of cholecalciferol, and adequacy of allocation concealment, omitting this study where there was heterogeneity within any subgroup.
We also conducted subgroup analyses, by repeating model 3 within separate categories according to sex, age, country and other variables (figure 1).
In the present study, the subgroup analyses were therefore repeated in analyses without claimants.
Further secondary analyses will involve planned subgroup analyses and will use multivariable regression models with appropriate interaction terms to ascertain any differential effects in relation to repeat caesarean section, choice of anaesthetic, and operator experience.
In evaluating trials of new drugs and procedures, the Food and Drug Administration does not accept such subgroup analyses, requiring a second trial for the subgroup that may benefit.
Subgroup analyses did not change the findings.
Thus, additional subgroup analyses are necessary.
This article quantifies the error rates associated with subgroup analyses.
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